MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number 24674

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located in the balloon sleeve approximately 7mm proximal from the distal tip.A visual and microscopic examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.

Event Description

It was reported that balloon rupture occurred.The target lesion was a thrombosis located in an artificial arteriovenous fistula at the left upper limb.A 5.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 3 atmospheres, the tip of the balloon was found to be leaking contrast.The device was removed and leaking was observed when pressure was applied.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable after the procedure.

Event Description

It was reported that balloon rupture occurred.The target lesion was a thrombosis located in an artificial arteriovenous fistula at the left upper limb.A 5.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 3 atmospheres, the tip of the balloon was found to be leaking contrast.The device was removed and leaking was observed when pressure was applied.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable after the procedure.It was further reported that the target lesion was 75% stenosed, moderately tortuous and severely calcified.

Manufacturer Narrative

B5: describe event or problem: updated.Device evaluated by mfr: a mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located in the balloon sleeve approximately 7mm proximal from the distal tip.A visual and microscopic examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16768544
• MDR Text Key: 313572657
• Report Number: 2124215-2023-17798
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793366
• UDI-Public: 08714729793366
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027637659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 60 KG